Strides Pharma gets FDA approval for Ibuprofen oral suspension

Strides Pharma Science Limited said that its stepdown fully-owned subsidiary — Strides Pharma Global Pte. Limited, Singapore, has secured approval from the US Food and Drug Administration (FDA) for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC).

The pain drug product from Strides Pharma is the generic of GlaxoSmithKline Consumer Healthcare Holdings (US)’s Infants’ Advil Concentrated Drops, 50 mg/1.25 mL (40 mg/mL) (OTC).

According to Strides Pharma Science, the FDA approval of its product further bolsters its Ibuprofen franchise for the American markets.

Strides Pharma gets FDA approval for Ibuprofen oral suspension. Photo courtesy of Joby.joe/Wikipedia.org.

Strides Pharma Global was given a Competitive Generic Therapy (CGT) designation by the FDA for its ANDA. Its product is the “first approved applicant” for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC).

The company will have a 180 days of Competitive Generic Therapy (CGT) exclusivity for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC), under section 505(j)(5)(B)(v) of the FD&C Act.